MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VIVACIT-E DUAL MOB BEARING 28MM I.D. 44MM O.D. SIZE F; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: cat# 00877502802 lot# 3118907 biolox⮠delta, ceramic femoral head, m, 㸠28/0, taper 12/14.G2: foreign: japan.The customer has indicated that the product will not be returned to zimmer biomet for investigation as the surgeon did not approve the return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial hip procedure.Subsequently, the patient underwent a revision procedure approximately 10 months later due to dissociation.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: e1; g3; h2; h3; h6.Visual examination of the provided pictures identified small scratches and indentations to the bearing outer spherical surface.No further evaluation can be made.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: VIVACIT-E DUAL MOB BEARING 28MM I.D. 44MM O.D. SIZE F
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19144037
• Report Number: 0001822565-2024-01341
• Device Sequence Number: 17975650
• Product Code: LPH
• UDI-Device Identifier: 00889024572706
• UDI-Public: (01)00889024572706(17)250630(10)64777279
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 110031012
• Device Lot Number: 64777279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown